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July 31, 2018 – The Fair Pricing Coalition (FPC) today commended Gilead Sciences for recent improvements to its Advancing Access program for Truvada (tenofovir disoproxil fumarate/emtrictabine) as pre-exposure prophylaxis (PrEP). In a July 24, 2018, letter to advocates, Gilead announced that its copay assistance maximum would be increased from $4,800 to $7,200 a year. This change goes into effect September 1. Additionally, beginning July 1, people vulnerable to HIV who qualify for the Advancing Access Medication Assistance Program (MAP) – which provides free drug to uninsured or underinsured individuals who meet annual income criteria – will remain eligible for 12 months instead of six months.

“For at least two years, the FPC – independently and as part of a coalition of community leaders concerned about Truvada pricing and access – have been pushing Gilead to make these long-overdue changes,” said Tim Horn, Chair of ad hoc coalition of HIV and hepatitis C virus activists. “We have documented cases where individuals with health insurance acquired HIV because they could no longer afford the out-of-pocket costs associated with taking Truvada after meeting the current copay assistance maximum allowance. And we’re pleased that people in need of free Truvada for PrEP through the MAP can count on access for 12 months, as opposed to having to reapply every six months.”

Despite the FPC’s repeated requests going back to the time of the launch of Truvada for PrEP, which would have allowed for a more detailed look at the financial need of those seeking the medication, Gilead refused to make public the methodology by which it arrived at its support levels. This forced the FPC and its colleagues in the community to gather information independently to document the support programs’ shortfalls and their consequences.

In a related matter, the Gilead announcement does not address the lingering concern expressed by advocates about the application of co-pay accumulators by commercial health insurance plans. In short, these co-pay accumulators may prevent copay assistance from being applied toward members’ deductible requirements, which can be very high, particularly for those on Bronze or Silver Affordable Care Act Marketplace plans with lower premiums.

“Copay accumulators are unacceptable barriers to essential medications,” said John Peller of the FPC. “They are a crude tactic by commercial insurers to deal with runaway prescription drug prices. While we appreciate that they are meant to drive patients to use cheaper generic drugs, there is no evidence-based generic alternative to Truvada for PrEP. People vulnerable to HIV are being caught in the middle of a war between insurance companies and drug manufacturers. We need a truce, which must begin with manufacturers – including Gilead – offering the discounts and rebates necessary for insurers to do away with this unfair and dangerous practice.”

Separately, Gilead has also announced that patient representatives from health care facilities can sign Advancing Access assistance program applications from adolescents that need PrEP. The FDA approved PrEP for adolescents earlier in 2018.

“We are glad to see Gilead recognize that not all youth will be able to get a parent or guardian’s signature to access programs that make PrEP affordable,” said Horn. “Homophobia and transphobia remain pervasive threats to sexual health in the U.S., particularly among queer youth. This program change should help improve access to Truvada for PrEP among vulnerable adolescents. The need for awareness of this access mechanism is critical and we encourage Gilead to do everything possible to inform health care providers, community leaders, and adolescents in need.”

According to figures released at the recent International Conference on AIDS held in Amsterdam, as of 2016 only about 7 percent of the 1.1 million people most at risk of acquiring HIV in the United States are accessing Truvada for PrEP. Among African American and Latino/a gay, bisexual and other men who have sex with men and transgender and cisgender women of color, PrEP uptake has been even less robust.

“The FPC has discussed many times with Gilead the multiple barriers to PrEP uptake, with the ever-escalating cost of Truvada not the least of those factors,” said Horn. “In this case, we are pleased with the expansion of support for those who need PrEP, all the while dismayed that such programs are even necessary.”

First PI-based single-tablet regimen debuts in the United States at record-high price.

July 23, 2018 – The Fair Pricing Coalition (FPC), an ad hoc coalition of HIV and hepatitis C virus (HCV) activists, today expressed its strong dissatisfaction with Janssen Therapeutics over its launch price for Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide). At a wholesale acquisition cost (WAC) of $41,784 a year, Janssen has set a record-high price for single-tablet antiretroviral regimens (STRs), ignoring the need for cost containment in HIV care and defying a groundswell of public and governmental demands for lower prescription drug prices.

“Symtuza is a useful addition to the HIV treatment toolbox for people living with HIV requiring a protease inhibitor and single-tablet dosing,” said FPC Chair Tim Horn. “However, the unprecedented price is very difficult to swallow. Symtuza is roughly $4,700 to $6,400 more than the current WAC prices for Stribild, Genvoya, and Biktarvy, until now the most expensive STRs on the market. We understand that Janssen isn’t charging any more than the components included in Symtuza, specifically Prezista (darunavir), Tybost (cobicistat), and Descovy (emtricitabine/tenofovir alafenamide), but the original development costs of these components have already been recovered many times over. Janssen missed the opportunity to introduce both an easier-to-take and less costly version of antiretrovirals that have all been available for some time now, which is unfortunate.”

When in doubt about STR research and development investments, FPC does advocate for parity pricing with the individual components – but with a very important stipulation. “We urge companies to factor out the egregious annual price increases taken on the components over the years and focus instead on what the component prices should be, based on either standard or medical inflation rates,” said FPC member Paul Arons. “We’re being punished twice – by price increases on older drugs that have snowballed compared to actual inflation rates, and on new drug products with prices based on these bloated benchmarks.”

Had prices of Symtuza’s component drugs risen only 28.8%, in line with the medical inflation rate over the years during which most of them were launched, the maximum price should have been $30,394 – $12,390 less than Janssen’s WAC. And with overall U.S. inflation, the WAC could reasonably have been 16.6% higher, or as low as $27,508. Having shared such calculations with Janssen, the Fair Pricing Coalition considers the company’s pricing decision especially regrettable.

The Symtuza launch price is particularly problematic in the context of comparable generic and quasi-generic drugs becoming widely available in the U.S. For example, the darunavir in Symtuza is one of two protease inhibitors (the other being atazanavir, which is now available as a stand-alone generic) classified as components of “Recommended Initial Regimens in Certain Clinical Situations” in the Department of Health and Human Services’ Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV, meaning they are not among the primary initial regimens. That means Symtuza is likely to have a more limited market than a drug that is listed in the guidelines for more widespread use. Common sense would dictate that Janssen would assign a lower price to a drug like Symtuza that is less clinically important.

Other components of Symtuza have generic or quasi-generic equivalents. “Using current and anticipated generic drug prices as a benchmark, a minimal fair price for Symtuza should have been below $10,000 annually,” said Horn. “Symtuza’s launch price goes to show that fairness rules aren’t being applied to newer HIV drug products with marginal advantages over older offerings, which is, at best, a shame, and at worst, a genuine threat to our stretched-thin systems of HIV care coverage.”

“We take some solace at the news Janssen has increased its copay assistance limit to $10,500,” said FPC member John Peller. However, the maximum eligibility for full indigent coverage under the Johnson & Johnson Patient Assistance Foundation remains at only 300% of the Federal Poverty Level – 40% short of the current pharmaceutical standard. Thus, the cost of Symtuza for a person living with HIV who earns just above that level could be as much as a full year’s income. “To what extent Janssen’s financial support programs defray out-of-pocket costs, particularly for such high-priced HIV drug products in an era of copay accumulators and an upswing in public and private policy attacks on products intended to defray patient costs, remains to be seen,” Peller added.

March 26, 2018 – The Fair Pricing Coalition (FPC), an ad hoc coalition of HIV and hepatitis C virus (HCV) activists, welcomes the U.S. Food and Drug Administration approvals and launches for Mylan’s Cimduo and Symfi Lo, with benchmark prices 40 percent lower than those of comparator drugs. Cimduo and two efavirenz-based products join a number of off-patent antiretrovirals (ARVs) – both generic and brands – entering the U.S. market that can potentially increase competition and lead to lower prices for purchasers and payors.

Cimduo, a coformulation of off-patent tenofovir disoproxil and lamivudine, is poised to compete with Gilead’s Truvada (tenofovir disoproxil/emtricitabine) and Descovy (tenofovir alafenamide/emtricitabine) for the treatment of HIV infection. Cimduo is not approved by the FDA for use as pre-exposure prophylaxis (PrEP to prevent HIV infection). The other combinations – coformulations of tenofovir disoproxil and lamivudine with either 400 mg efavirenz (Symfi Lo) or 600 mg efavirenz (Symfi) – are comparable with Gilead’s Atripla (tenofovir disoproxil/emtrictabine/efavirenz).

The Cimduo WAC (wholesale acquisition cost) price is estimated to be $12,000 a year, compared with approximately $20,100 for Truvada and Descovy. It is expected to be available in pharmacies in April. The WAC price for Symfi Lo, now available, is approximately $19,600, compared to approximately $32,700 a year for Atripla (Symfi, containing 600 mg efavirenz, has not yet launched). Actual prices will vary following required and negotiated discounts and rebates for public and private payors.

“This is a notable advancement in fair HIV drug pricing,” said Tim Horn, Chair of the FPC and Deputy Executive Director of HIV and HCV Programs of the Treatment Action Group. “Not only is Cimduo a safe and effective first-line regimen component for many people and the efavirenz-based single-tablet regimens good switch options for individuals doing well on Atripla, they may cut costs for individual patients and at least some public and private insurers. With the growing number of branded and generic drugs containing commonly used off-patent ARVs entering the U.S. market, differences in cost between comparable HIV treatment regimens are an important consideration. And while the societal benefits of reduced health care spending are well known, lower treatment costs could translate to significantly increased access to HIV treatment and less discrimination within the health insurance market.”

The FPC engages with HIV drug manufacturers to advocate for low WAC pricing, along with significant discounts for public payors, not only to ensure that all people living with and vulnerable to HIV infection have access to essential treatment and prevention, but also in recognition of the larger societal benefits of affordable prescription drug pricing. In 2016 alone, the U.S. spent more than $328 billion on retail prescription drugs, according to the Centers for Medicare & Medicaid Services.[1] HIV drug regimens, with annual WAC prices exceeding $30,000, were the costliest Medicaid and third-costliest Affordable Care Act Exchange plan therapy class expenditures in 2017, according to per-member-per-year analyses conducted by Express Script.[2]

“HIV drug spending simply isn’t sustainable,” said Lynda Dee, a founding co-chair of the FPC and the Executive Director of AIDS Action Baltimore. “Less than half of the 1.1 million people living with HIV are on treatment and have suppressed viral loads. We need to get more people on treatment with the appropriate support systems to ensure linkage to, and engagement in, care and adherence. Resources are finite, however, especially for diseases of public health significance. We’re already seeing public and private insurers implementing significant cost-containment measures against high-cost regimens because they are priced beyond what taxpayers and the insurance markets can reasonably bear.”

Cost Savings

Generic drug products save the U.S. healthcare system billions of dollars a year: $253 billion in savings were generated in 2016 alone, with $1.67 trillion in savings over the past decade.[3] This translates into public health care savings, private health insurance premium cost containment, and reduced out-of-pocket spending by consumers. With increasing demand for safe and effective off-patent drug products, competition between manufacturers results in further price reductions and increased savings.

Cimduo, Symfi, and Symfi Lo are not technically generic drug products, but instead brand-name products without exclusivity protections.[4] This is the first time the U.S. Food and Drug Administration (FDA) has approved coformulations containing these specific ARVs – all of whose long-time patient protections have expired – so they are technically innovator products. Because Mylan did not conduct its own safety or efficacy research for Cimduo, Symfi, or Symfi Lo, they do not qualify for market exclusivity. In turn, other manufacturers can commercialize similar products. The FPC encourages this, not only to increase the potential for additional cost savings but also to decrease the likelihood of egregious annual price increases.

Manufacturer competition has been critical to cost-containment for global HIV treatment programs, with annual negotiated prices of $46–$84 and ~$97–$160 for coformulations comparable to Cimduo and Symfi/Symfi Lo, respectively, available to many low-income national governments.[5] “Mylan made minimal research and development investments in commercializing these drug products,” said Horn. “Forty percent lower WAC prices than comparator products are certainly a step in the right direction. But we can do much better in the U.S. with competition.”

Currently approved bona fide generic antiretrovirals available in the U.S. include stand-alone abacavir, atazanavir, efavirenz, lamivudine, nevirapine, ritonavir, tenofovir disoproxil, zidovudine, and coformulated abacavir/lamivudine, all of which are bioequivalent versions of FDA-approved innovator products.[6]

Cimduo and the efavirenz-based single-tablet regimen WAC prices have the potential to result in significant cost savings for some payors. Employer-based and Affordable Care Act Marketplace health insurance plans are well poised to pay significantly less for these products than they do for Truvada, Descovy and Atripla.[7] Should commercial plans start placing cheaper medications like Cimduo, the Symfi products, or generics on their preferred drug lists, manufacturers of traditional brand-name ARVs and coformulations may start offering discounted pricing, likely in the form of increased rebates to pharmacy benefit managers (PBMs). [8] The opposite is also true: manufacturers of traditional brand-name ARVs may increase prices, particularly if lower-cost products cut into utilization and sales.

“Lower-price brand and generic drugs are important market forces,” says Horn. “Fair pricing advocates can – and should – use this as leverage to ensure the lowest possible prescription drug costs for purchasers and payors. Any significant price increases of traditional brand-name drugs spurred by lower-cost competitors will be met with resistance.”

“Cost savings to commercial plans need to start translating into cost savings for patients and employers,” said FPC member David Evans of Project Inform. “Launching new drug products – including off-patent products – at low, transparent prices, with strict control over annual price increases, would negate the need for secretive deals between pharmaceutical companies, commercial plans, and their pharmacy benefit managers. Too many plans don’t pass along cost savings in the form of reduced premiums, taxpayer savings, or lower out-of-pocket costs.”

Because of the broken U.S. health care system, which has resulted in remarkably complex drug pricing regulations, it is less certain how much the introduction of Cimduo and the Symfi products will actually save Medicaid, AIDS Drug Assistance Programs (ADAPs), and 340B programs. Ceiling prices, from which discounts to these public payers are calculated, are confidential, determined by opaque processes involving discounts and rebates required by law or negotiated privately between manufacturers, purchasers, or public payors.

For example, Truvada is not only subject to a 23.1% price decrease off the confidential average manufacturer price (AMP; which on average is slightly lower than the WAC) for Medicaids, ADAPs, and 340Bs, the product’s multiple price increases since its approval in 2004 have far exceeded inflation rates and have therefore triggered significant additional “penalty” rebates/discounts for these programs. Mylan will need to supplement its 40% list price differences (vs. Truvada, Descovy, and Atripla) and mandatory 23.1% rebate with substantial voluntary rebates to Medicaid, ADAPs, and 340B programs if they are to exceed the discounted Truvada, Descovy, and Atripla prices and result in significant cost savings.

“We strongly encourage Mylan and other multi-source ARV manufacturers to compete with each other and brand-name monopoly products across all payor systems, and to negotiate with groups like the ADAP Crisis Task Force,” said FPC member Murray Penner, Executive Director of NASTAD. “It is fortunate that Medicaid, ADAPs, and 340B programs are able to take advantage of discounts and rebates for older ARVs, but given rapid changes in health care dynamics, including drugs preferred by clinicians or recognized by independent bodies and insurance marketplaces, good faith negotiations will be critical.”

“These are very cheap drug products to manufacture and distribute – at profit – to meet global HIV treatment needs,” said Horn. “Even after allowing for FDA fees and shipment costs, there’s no reason why multi-source brand and generic products can’t be discounted so that cost savings are ensured across all U.S. payor systems.”

Some bona fide generic ARVs may also be more expensive to some public payors, compared with post-rebate costs for older brand-name products. With competition among generic manufacturers, however, the potential for cost savings increases.

It should be noted that unlike true generics, pharmacies cannot automatically substitute Cimduo and Symfi products for their competitor combination products from Gilead Sciences. A clinician would have to specify the new combination on the prescription. Pharmacies can, however, substitute brand-name products with generic competitors. These include Epzicom (abacavir/lamivudine), Reyataz (atazanavir), and Norvir (ritonavir).

Cost Implications for People Living with HIV

Lower out-of-pocket expenses associated with cheaper treatment regimen components and coformulations placed on less-expensive formulary tiers by commercial plans are a significant driver of generic drug product demand in the United States. However, all manufacturers with monopoly HIV drug products offer generous copay/coinsurance assistance, with ADAPs also providing out-of-pocket assistance. “If commercial plans actually place cheaper off-patent HIV drugs on tiers with lower cost-sharing – and there’s no guarantee they will – this could spell relief for people living with HIV covered by plans that don’t recognize manufacturer copay assistance programs – a practice that is growing,” said FPC member Andrea Weddle, Executive Director of the HIV Medicine Association (HIVMA).

Copay and coinsurance assistance provided by manufacturers may also be an important consideration for people living with HIV. Mylan, for example, is providing copay assistance for Symfi Lo and is expected to offer copay assistance for Cimduo and Symfi as well. This may be subject to change if other manufacturers receive FDA approval for direct competitors. While generic manufacturers generally do not offer copay assistance – West-Ward, a manufacturer of generic ritonavir, is providing copay assistance through September 2018 (at which point it will likely face competition from other generic manufacturers) – the FPC continues to advocate for these programs to defray out-of-pocket costs associated with HIV treatment.

Treatment Choice Implications for People Living with HIV

Cimduo and the generic coformulation of abacavir/lamivudine are expected to be the most acceptable to people living with HIV and providers because they are components of recommended initial regimens for most people living with HIV, according to the Health and Human Services’ Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV.[9] Cimduo and abacavir/lamivudine, for example, are recommended for use in combination with the innovator product dolutegravir (Tivicay).

The Symfi products may have less appeal to people living with HIV starting treatment for the first time, as efavirenz plus tenofovir disoproxil and either emtricitabine or lamivudine are Guidelines recommended regimens only in certain clinical situations, largely due to the central nervous system side effects associated with efavirenz. However, thousands of U.S. residents living with HIV are still using Atripla and, for them, the reduced cost of the Symfi products – and the lower dose of efavirenz in Symfi Lo, which may be associated with fewer adverse events[10] – may provide alternatives to consider.

Other generic drug-based products of interest for people with HIV include the protease inhibitor atazanavir and ritonavir for boosting which, like efavirenz, are recommended by the Guidelines in certain clinical situations.

Lamivudine is widely considered interchangeable with emtricitabine.[11] The interchangeability of tenofovir disoproxil with tenofovir alafenamide (a component of Descovy, Genvoya, Odefsey, and Biktarvy) is more controversial. As noted by the Guidelines:

TDF has been associated with lower lipid levels than TAF and ABC. However, TDF use has been associated with declines in kidney function, proximal renal tubulopathy (leading to proteinuria and phosphate wasting), and reductions in bone mineral density (BMD). These tenofovir toxicities are less common with TAF, which results in lower plasma tenofovir concentrations than TDF. As a result, the main advantages of TAF over TDF are TAF’s more favorable effects on renal markers and BMD.

What remains unclear is if tenofovir alafenamide is a necessary regimen component option, compared with tenofovir disoproxil, for all people living with HIV, notably those beginning HIV treatment with normal kidney function and bone health. For such patients, tenofovir disoproxil-inclusive regimens like Cimduo may be a suitable option, in alignment with the Guidelines. [12]

Another implication is payor preferences for lower-cost drug products that may necessitate breaking up single-tablet regimens. While single-tablet regimens, particularly those recommended by the Guidelines for most people living with HIV, are preferred by some patients and providers because they are easier to use and are associated with fewer monthly copayments, clinical trial data to support or refute the superiority of single-tablet regimens over once-daily multi-tablet regimens—which would include regimens containing Cimduo and generic abacavir/lamivudine—are limited.[13]

“Once-daily multi-tablet regimens containing Cimduo or abacavir/lamivudine would undoubtedly be safe, effective, and easy to take by many people living with HIV,” said Horn. “FPC strongly encourages people living with HIV to discuss their treatment choices in the context of drug pricing and cost savings with their providers. We all share the burden of high health care costs and drug prices, some more directly than others. Even in the absence of personal benefits of starting or switching to a lower-cost regimen consistent with today’s standard of care, there are societal benefits to consider.”

“Payor preferences for cheaper competitive products, in the form of step therapy requirements and denials of coverage for higher-cost monopoly products, can be intrusive and dangerous. People living with HIV are not a homogeneous patient population; individualized therapy to meet adherence needs is still essential,” added Horn. “To prevent these cost-containment measures, we urge the leading traditional manufacturers of HIV drug products—Gilead, ViiV, Merck, and Janssen—to price their products competitively with emerging lower-price options.”

Community advocates, health care providers, and people living with HIV should watch for overly restrictive insurance company practices, including cumbersome processes associated with switching from either tenofovir disoproxil- to tenofovir alafenamide-containing regimens or multi-tablet to single-tablet regimens. FPC encourages the reporting of egregious examples via the SpeakUP portal maintained by the AIDS Foundation of Chicago and the Center for Health Law and Policy Innovation at Harvard Law School: SpeakUP.HIV.

[3] Association for Accessible Medicines. Generic drug access and savings in the U.S. 2017. Available from: https://accessiblemeds.org/sites/default/files/2017-07/2017-AAM-Access-Savings-Report-2017-web2.pdf

[9] HHS Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV. 2017 Oct 17. https://aidsinfo.nih.gov/guidelines/html/1/adult-and-adolescent-arv/37/

[12] HHS Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV. 2017 Oct 17. https://aidsinfo.nih.gov/guidelines/html/1/adult-and-adolescent-arv/37/

[13] HHS Panel on Antiretroviral Guidelines for Adults and Adolescents. Limitations to treatment safety and efficacy: Adherence to the continuum of care. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV. 2017 Oct 17. https://aidsinfo.nih.gov/guidelines/html/1/adult-and-adolescent-arv/30/adherence

January 25, 2018

A deeply concerning issue has been brought to our attention: Gilead Sciences is limiting access to Truvada (tenofovir disoproxil plus emtricitabine) as a component of nonoccupational postexposure prophylaxis (nPEP) through its patient assistance program (PAP) to once in a lifetime, with hardship review criteria and processes for subsequent prescriptions that have not been clearly articulated and are likely a considerable barrier to nPEP by uninsured and underinsured U.S. residents. We believe this policy is unethical and incompatible with CDC guidelines and we implore you to immediately end such an unreasonable policy, in favor of a transparent and accommodating policy that ensures unencumbered and streamlined access to nPEP for those vulnerable to HIV infection.

While no randomized, placebo-controlled clinical trials have been conducted to fully evaluate the safety and efficacy of nPEP, including regimens containing Truvada, numerous observational studies in men who have sex with men, victims of sexual assault and other populations have yielded strong evidence that nPEP can reduce the risk of acquiring HIV infection when started within 72 hours of exposure and continued for 28 days.[1]

We concur with the following public health guidance from the U.S. Centers for Disease Control and Prevention (CDC):

nPEP should be provided only for infrequent exposures. Persons who engage in behaviors that result in frequent, recurrent exposures that would require sequential or near-continuous courses of antiretroviral medications (e.g., HIV-discordant sex partners who inconsistently use condoms or [people who inject drugs] who often share injection equipment) should not be prescribed frequent, repeated courses of nPEP. Instead, health care providers should provide persons with repeated HIV exposure events (or coordinate referrals for) intensive sexual or injection risk-reduction interventions, and consider the prescription of daily oral doses of the fixed-dose combination of TDF and FTC (Truvada, Gilead Sciences, Inc., Foster City, California) for PrEP. However, if the most recent recurring exposure is within the 72 hours prior to an evaluation, nPEP may be indicated with transition of the patient to PrEP after completion of 28 days of nPEP medication.[1]

Gilead’s once-in-a-lifetime PAP allowance for Truvada as nPEP is, at best, incongruent with this guidance. First and foremost, there are important variations on the spectrum between one-time utilization of nPEP and “sequential or near-continuous courses of antiretroviral medications.” Examples include individuals who rely primarily on condoms to prevent HIV infection with occasional lapses in use or condom failures and sexual assault victims.

Second, not all nPEP users are effectively screened for PrEP, have easy and affordable access to knowledgeable and culturally competent PrEP providers and laboratory testing, or are deemed suitable candidates for PrEP.

Third, the CDC guidance is intended for health care providers and people with nonoccupational risk factors for HIV infection. They are not binding regulations for pharmaceutical companies manufacturing any of the preferred or alternative components of nPEP or the PAPs ensuring their availability to uninsured or underinsured individuals meeting financial eligibility criteria. Manufacturers’ overly stringent interpretation of public health guidance should in no way supersede critical decision making by health care providers and their patients, particularly when it comes to a drug product recommended by CDC for emergency medical care to prevent HIV infection.

Fourth, any effort by Gilead to steer individuals to PrEP – particularly as it commercializes the only U.S. Food and Drug Administration-approved regimen for PrEP – through dubious and overly stringent restrictions to nPEP access through its PAP is unethical.

Fifth, while we understand that a “hardship review” can be requested in the event a second (or subsequent) course of nPEP is prescribed by a health care provider and must be accessed through the PAP, we cannot begin to comprehend how it is Gilead’s responsibility to determine whether a person with a potential subsequent exposure to HIV should or should not receive an important intervention to prevent infection. Not only is “hardship review” highly stigmatizing language, it strongly indicates an added level of scrutiny that ultimately translates into a barrier in a process that is extremely time-sensitive and should be streamlined wherever possible.

In addition to the alarming PAP restriction that necessitates this letter and immediate rectification by Gilead, we are again faced with a Gilead policy with a direct effect on the lives of people living with and vulnerable to HIV infection that has not been vetted or discussed with community advocates. We trust that, with this particularly egregious example of dangerous policy, Gilead Sciences will firmly establish mechanisms for meaningful community engagement.

In the meantime, and without delay, we urge Gilead to lift its once-in-a-lifetime PAP access policy for Truvada as a component of nPEP—thereby minimizing the need for the additional, time-consuming onus of hardship requests–and instate a policy that fully supports the capacity of health care providers and patients to make their own informed, medically sound decisions regarding primary HIV prevention. We would also appreciate a written response to this letter, specifically noting changes to Gilead’s policy for nPEP access through its PAP and the timeline for implementation.

Sincerely,

Tim Horn
Chair
Fair Pricing Coalition

Mark Harrington
Executive Director
Treatment Action Group

Murray Penner
Executive Director
NASTAD

[1] U.S. Centers for Disease Control and Prevention. Updated guidelines for antiretroviral postexpsoure prophylaxis after sexual, injection drug use, or other nonoccupational exposure to HIV–United States, 2016. 2016 May. Available from: https://stacks.cdc.gov/view/cdc/38856

NEW YORK, NY, AUGUST 4, 2017 – The Fair Pricing Coalition (FPC) today applauded U.S. Food and Drug Administration approval of the first eight-week pangenotypic, ribavirin-free, curative regimen for hepatitis C virus (HCV) infection and expressed its appreciation for a wholesale acquisition cost (WAC) that should translate into improved affordability, with fewer access restrictions, to insurers and people living with the virus.

“This is very good news for people living with HCV in the United States,” said Tim Horn, co-chair of the Fair Pricing Coalition. “The majority of people using Mavyret will be able to complete treatment in just eight weeks, compared with standard 12-week courses, depending on their treatment history and cirrhosis status. The favorable U.S. launch price set by AbbVie should also be good news to public and private payors, resulting in fewer access barriers, a substantial increase in the number of cures, and significant progress toward HCV elimination. FPC remains committed to ensuring access the U.S. and, globally, working with its partners toward affordable pricing in low- and middle-income countries.”

The U.S. WAC price for 12 weeks of Mavyret therapy has been set at $39,600. For patients without cirrhosis who are new to treatment—approximately 78% of people living with the virus in the U.S., according to AbbVie’s estimates—an eight-week course of treatment is recommended, with a WAC price of $26,400. This price is in stark contrast with the WACs set for its pangenotypic predecessors, including Gilead’s Vosevi and Epclusa (both $74,760 for 12 weeks of therapy), and is by far the lowest WAC of any direct acting antiviral (DAA) regimen currently available for HCV infection in the U.S.

“FPC believes that all direct acting antiviral combinations for HCV should be priced not higher than $40,000 in the U.S., with the ability for payors to meaningfully negotiate and get to a place where they would be willing to increase access and cure more people living with HCV,” said Emalie Huriaux, FPC co-chair. “At this WAC price point, public payors, including Medicaid programs and correctional systems with limited budgets, would be in a much better position to get to a price that is both high value and cost-savings at best or cost-neutral at worst.”

According to a 2015 analysis by the University of California, San Francisco, and the Institute for Clinical and Economic Review, a price range for highly curative HCV treatment of $34,000 to $42,000 should serve as a benchmark for keeping U.S. health system cost increases below a threshold of 0.5%–1.0%.[1] According to ICER, this threshold budget impact for a single new treatment is viewed by many payors as manageable, without resorting to severe treatment delays or cuts in others services.

“It’s clear that our discussions with AbbVie in the lead-up to approval were not in vain,” said Huriaux. “The company did the right thing in launching with a WAC price that is, we believe, within the bounds of what the U.S. market can reasonably bear—public and private payor negotiations will ultimately reduce the cost further. It is now incumbent upon payors to eliminate restrictions, such as limiting treatment to only patients with advanced liver disease and degrading evaluations related to drug and alcohol use, neither of which are consistent with evidence-based guidelines. State Medicaid programs and correctional systems have, understandably, cried foul with respect to ensuring coverage for these life-saving therapies. With Mavyret’s significant price differential, the issue of unencumbered access is now in payors’ hands. U.S. activists have worked hard to achieve the former; we must now focus intently on the latter.”

Mavyret, a once-daily regimen containing glecaprevir (an NS3/4A protease inhibitor) and pibrentasvir (an NS5A inhibitor), was approved on August 3rd as curative therapy for adults with HCV genotypes 1-6 without cirrhosis or with mild cirrhosis, including patients with moderate to severe kidney disease and those who are on dialysis. A game changer, Mavyret shows high sustained virologic response rates (SVRs) of 95 percent for people with the more difficult-to- treat HCV genotype 3, without cirrhosis, with 8-week treatment. Mavyret is also approved for adult patients with HCV genotype 1 infection who have been previously treated with a regimen either containing an NS5A inhibitor or an NS3/4A protease inhibitor, but not both.

Clinical trial data submitted by AbbVie in their approval application indicate that Mavyret is equally effective in people coinfected with HIV and HCV. As with all current HCV curative formulations, the label carries a black box warning to screen for and treat Hepatitis B co-infection.

NEW YORK, NY, MARCH 31, 2017 ­– With growing bipartisan support for feasible measures to control skyrocketing prescription medication costs, a Health Affairs Blog post published today describes four proposals to strengthen and modernize cost control measures that already exist in the United States. The Blog post is based on a critical analysis, Tackling Drug Costs: A 100-Day Roadmap, produced in conjunction with the Fair Pricing Coalition (FPC) and circulated widely among Congressional leadership.

“Federal legislation has not maintained pace with drug manufacturers’ tactics to circumvent statutes and regulations already in place to control prescription drug costs,” said Sean Dickson, Senior Manager, Health Systems Integration, at NASTAD (National Alliance of State and Territorial AIDS Directors), FPC member and lead author of the report. “Political inertia and existing statutory penalties are failing to stop exorbitant drug prices. Our analysis clearly indicates that the Trump Administration and Congress can readily fix the existing framework to reduce federal drug spending and discourage egregious price increases in the private market.”

The Health Affairs Blog post highlights four pathways to promptly modernize and strengthen existing regulations and statutes to control drug costs, drawing on existing authority and concrete legislative actions:

Fix the Formulas: Modernize and strengthen current ceiling price formulas to ensure that government payers are not paying more than commercial payers;

Enhance Existing Penalties: Remove inflation penalty caps, increase penalties on drugs with the most egregious price hikes, and apply penalties to new drugs with launch prices far in excess of top sellers in the same class;

Pool Purchasing Power: Increase inter- and intra-agency collaboration to consolidate Federal and State negotiating power; and

Pull Back the Curtain: Buttress existing transparency tools while studying the effects of additional manufacturer price and payer cost disclosures.

“It is high time for the government to clamp down on drug pricing tactics that drive up health care costs and invariably hurt health care consumers,” said Tim Horn, Deputy Executive Director of HIV & HCV Programs at Treatment Action Group (TAG), lead author of the Health Affairs Blog post and collaborating author on Tackling Drug Costs. “There’s a populist impetus for prescription drug cost restraints and growing support for executive and legislative action. The Trump Administration and Congress must honor campaign promises in this regard and move swiftly and decisively to reduce drug prices while incentivizing scientific ingenuity and discovery – the health care system, taxpayers, and those who rely on life-saving prescription drugs, are demanding it.”

NEW YORK, NY, February 27, 2017–The Fair Pricing Coalition (FPC) today expressed its dismay and frustration at manufacturers of some of the most frequently prescribed antiretrovirals for treatment of HIV, citing exorbitant Wholesale Acquisition Cost (WAC) price increases ushered in with the new year. The WAC price increases implemented by these industry leaders show complete disregard for an annual FPC year-end appeal, which included an additional 90 organizational and 61 individual signatories.

“Pharmaceutical corporations continue to make annual, sometimes twice-yearly, incremental increases on HIV drugs, and their arguments that the increases are necessary to ensure new drug discovery and don’t contribute to nationwide limitations in care for all are less and less compelling every year,” said FPC Co-chair Emalie Huriaux. “These increases are like a death by a thousand paper cuts, slowly bleeding money from consumers and threatening the ability of people with HIV to access lifesaving treatment. The FPC continues to make this point year after year, and here we are again, addressing unsustainable WAC increases.”

The 2017 WAC price increases for leading antiretrovirals are two to three times the ten-year consumer price index (CPI) average of 2.5 percent; they are also higher than all medical CPI categories, which average 2 to 3 percent and are driven in part by unrestrained drug pricing. “While other companies, such as Apple or Samsung, are also quite profitable, people don’t die from the lack of an iPhone or television,” said Huriaux. “The same cannot be said about medications for people with life-threatening diseases like HIV.”

“What’s really frustrating is the growing trend among manufacturers to shift responsibility for these price increases onto other parties—pharmacy benefit managers retained by insurers to secure lower drug costs, discounts and rebates to public payers, even copay assistance programs,” said FPC Co-chair Tim Horn. “The fact remains, however, that these concessions are necessary primarily because WAC prices are beyond what the market can reasonably bear. Breaking the cycle depends, in large part, on manufacturers lowering their prices.”

Notable WAC price increases reported in January 2017 include ViiV’s 7.9% increase on Triumeq, Tivicay, and Selzentry (no price increase was reported for Epzicom, which now faces generic competition); Gilead’s 6.9% increase on its three TAF-inclusive products, Descovy, Genvoya, and Odefsey, plus two price increases on Atripla totaling 6.6%; Bristol-Myers Squibb’s 6% increase on Reyataz, Sustiva, and Evotaz; AbbVie’s 4.9% increase on Kaletra; Janssen’s 7.9% increase on Intelence, Prezcobix, and Prezista; and Merck’s 7.9% increase on Isentress. The WAC prices for several antiretrovirals, including Atripla, Reyataz, Truvada, Sustiva, and Viread, are now double or triple their launch prices.

“These price increases have real-life consequences,” said FPC member John Peller, President & CEO of AIDS Foundation Chicago. “They drive health insurance premiums higher every year, making it harder for all of us to afford insurance. They force insurance companies to make people pay more for lifesaving medications or add administrative barriers, like prior authorization, that cause endless access delays.”

No increases have been announced so far on the recently developed Direct Acting Antivirals (DAA) for treating the hepatitis C virus (HCV). Those drugs were launched at prices so high that the resulting public outcry led to Congressional hearings.

The FPC notes that all DAA manufacturers, with the exception of Gilead, have negotiated discounts with the ADAP (AIDS Drug Assistance Program) Crisis Task Force. “We applaud the work of the Task Force and the manufacturers that have agreed to provide discounts to ADAPs, thereby making curative DAA treatment much more accessible to people coinfected with HIV and HCV,” said Horn. ADAPs can access these medications at the 340B price, which represents at least a 23.1% discount off of the Average Manufacturers Price. However, even at the 340B price, the Task Force noted in a June 30, 2016, update, prices for Gilead’s HCV treatments are excessive compared with the negotiated prices of other companies.

The FPC submitted its letter with 151 signatories to all of the major HIV and HCV drug manufacturers in November 2016, demanding a price freeze or, if absolutely necessary, no more than one price increase annually, not to exceed the overall increase in the medical CPI for the preceding year. Letters also reiterated the need for more robust company patient savings programs to offset skyrocketing out-of-pocket costs associated with these expensive medications being placed in specialty drug tiers, and cited increasing U.S. government opposition to excessive drug pricing. While such programs are under fire from the health insurance industry and large payer groups, who argue that the programs steer people away from cheaper drugs that are equally effective, it has been well documented that expensive co-payments and co-insurance lead to gaps in treatment for people with HIV or HCV, who don’t have cheaper alternatives and who would experience significant medical harm.

In response, most manufacturers arranged conference calls with the FPC for further discussion of their pricing principles. Claiming legal proscriptions, however, companies stated while they can receive input before pricing increases, they can only notify the FPC and general public after the price increases have been implemented. While the companies reiterated their support for patient access, primarily through patient assistance and co-pay assistance programs, they nevertheless uniformly proceeded to raise WAC prices unreasonably anyway.

The Fair Pricing Coalition announces the release of “Tackling Drug Costs: A 100-Day Roadmap,” an analysis of existing federal statutes and regulations that should be strengthened to dramatically lower the prices of drugs and biologics in the U.S. The report, distributed to the President-elect’s transition team and Congressional leaders, provides a roadmap that can be implemented quickly on the heels of growing bipartisan support for feasible measures to control the skyrocketing costs of prescription medications.

“The American drug pricing system is in disrepair,” said FPC member Sean Dickson, lead author of the report and Senior Manager, Health Systems Integration, at NASTAD (National Alliance of State and Territorial AIDS Directors) in Washington, DC. “Political inertia and existing statutory penalties are failing to stop exorbitant drug prices. Significant restructuring of payer systems is certainly one approach. However, our analysis clearly indicates that the incoming Administration and Congress can readily strengthen and modernize the existing framework to reduce federal drug spending and discourage egregious price increases in the private market.”

Cost control regulations and statutes already exist. Federal legislation, however, has not maintained pace with drug manufacturers’ tactics to circumvent these measures. The report highlights four pathways to promptly modernize and strengthen existing regulations and statutes to control drug costs, drawing on existing authority and concrete legislative actions:

Fix the Formulas: Modernize and strengthen current ceiling price formulas to ensure that government payers are not paying more than commercial payers;

Enhance Existing Penalties: Remove inflation penalty caps, increase penalties on drugs with the most egregious price hikes, and apply penalties to new drugs with launch prices far in excess of top sellers in the same class;

Pool Purchasing Power: Increase inter- and intra-agency collaboration to consolidate Federal and State negotiating power; and

Pull Back the Curtain: Buttress existing transparency tools while studying the effects of additional manufacturer price and payer cost disclosures.

“FPC has spent many years pleading with the pharmaceutical industry, particularly those responsible for manufacturing lifesaving human immunodeficiency virus (HIV) and hepatitis C virus (HCV) drugs and biologics to keep their prices in check as to not create hugely problematic access barriers,” explained FPC Co-Chair Tim Horn, co-author of the report and the Deputy Executive Director, HIV & HCV Programs, at Treatment Action Group (TAG) in New York. “Pharma clearly isn’t listening and it appears to be doubling down on messaging and lobbying efforts to justify its egregious pricing.

“It is high time for the government to clamp down on drug pricing tactics that drive up health care costs and invariably hurt health care consumers,” Horn said. “Bipartisan Congressional support for cost restraints has grown and President-elect Trump, who has voiced support for a more proactive role of government in drug pricing, must forcefully confront one of the most significant barriers to lifesaving treatment in the U.S.”

“Manufacturers continue to price prescription drugs and biologics beyond what the U.S. market and healthcare consumers can reasonably bear,” said FPC Co-Chair Emalie Huriaux, who is also Director of State and Federal Affairs at Project Inform in San Francisco. “For people living with HCV, in particular, significant challenges accessing curative treatment have become commonplace, particularly among those accessing care through federal or state programs. Enough is enough. With this roadmap to quickly control drug costs without jeopardizing market-driven ingenuity, along with other emerging proposals for sweeping reforms to rein in domestic and global drug spending, we hope that the Administration and 115th Congress will prioritize swift and meaningful action against runaway drug pricing.”

The undersigned organizations and individuals submit this letter in response to price increases you took in 2016 on antiretroviral (ARV) drugs to treat HIV, and in advance of what has become a standard New Year’s practice of boosting Wholesale Acquisition Costs (WACs) for ARVs without regard to how that will affect patient access to these life-saving treatments. We also write to express concerns about future price increases for direct acting antivirals (DAAs) for the treatment of Hepatitis C (HCV), which are already priced beyond what insurers and people living with HCV can reasonably bear.

Included below, please find the U.S. Fair Pricing Coalition’s table documenting two years of increases, along with its pricing and access principles and requests. These issues are especially relevant in light of resulting cost-containment restrictions instituted by both public and private payers.

Since 2010, some ARV prices have even been raised twice in the same year, the most blatant example being Gilead’s dual hits in 2016 on Complera and Stribild, totaling 14.3% and 12.1% respectively. In all cases, the price increases exceed the rise in the Consumer Price Index (CPI), a measure of inflation, sometimes two to three times or more. They even exceed the medical CPI, which is always more than the overall CPI, arguably due in part to excessive drug prices. In fact, average annual ARV increases have ranged from 5% to 8% ­— even higher in some instances — while the overall CPI has averaged 2.5% per year over the past 10 years.

We also have overwhelming evidence that exorbitant drug pricing has resulted in hepatitis C (HCV) patients being unable to access DAA combinations, which achieve up to 99% cure rates with minimal side effects. As examples of resulting obstacles, payers have initiated specialty tiering, coinsurance, and prior authorization restrictions for HIV and HCV drugs, with additional cost-containment measures in place for DAAs, such as fibrosis scoring qualifications, prescriber limitations, sobriety requirements, and detrimental rationing among incarcerated individuals.

Generally ignoring urgent community pleas to refrain from any price increases, and certainly no increases over medical CPI, the companies listed here have raised prices as follows (the columns show percent increases in 2015 and 2016, and overall since FDA approval):

The FPC and signers of this letter firmly believe that upwardly spiraling drug prices are already beyond the limit of any conceivable justification, are unsustainable, and will further prevent HIV and HCV patients from accessing life-saving ARVs and DAAs. Thus, we urgently request that you agree to a two-year price freeze on ARVs and DAAs to offset, in part, the price increases of your ARV drugs since FDA approval, and the initial WAC prices of your Hepatitis C DAAs. We are aware of industry claims that no one actually pays the WAC price. However, we also know that all discounts start from that point, resulting in inflated, inconsistent, and unsustainable consumer prices.

If companies insist on instituting price increases, at the very most they should occur only once annually, no sooner than two years after FDA approval, and they should not exceed the overall increase in the medical CPI for the preceding year.

If any manufacturer of ARVs takes more than one annual price increase above medical CPI, or in the case of DAAs, any price increase whatsoever, we pledge to mobilize to notify and inform the public at every possible opportunity about any and all unreasonable and unfair pricing policies. President-elect Trump and Congressional leaders have provided bipartisan support for reining in excessive drug pricing, another pragmatic reason to curb your annual overreach. We urge you to heed these warnings, and reject any contemplated price increases.

• Institute a price freeze for all currently approved HIV and HCV drugs for the next two years, and for a two-year period henceforth from the date of FDA approval on all new HIV and Viral Hepatitis drugs.

• Thereafter, if you must, take no more than one price increase annually, and at no more than the rise of the medical CPI. In addition, provide the FPC with prior notice within the bounds of relevant laws, of the rationale for all price increases, and if possible, a call in advance to discuss any “potential” increase.

Access Programs

Robust access programs are a necessity to assist uninsured and underinsured individuals in obtaining necessary medications, and have become increasingly important for adequately insured individuals facing substantial out-of-pocket costs resulting from payer cost-containment measures. Even with a company’s commitment to such programs, further changes are necessary in order to adapt to the changing healthcare environment and the mounting burden of increasing drug prices. Nor can these access programs be used as an excuse for a company’s continued excessive pricing tactics.

• Where allowable by law, provide all privately insured individuals living with HIV and/or HCV with 100% coverage of all out-of-pocket (OOP) costs, including co-pays, deductibles, co-insurance or any other related charges for all HIV and Viral Hepatitis prescriptions, including mail order prescriptions. We make this request in light of reports from individuals throughout the U.S. who are not taking their medications because they cannot afford the rapidly increasing OOP costs.

• Donate to a highly functioning and qualified foundation pursuant to all relevant laws, particularly to assist Medicare Part D recipients who cannot use manufacturers’ programs to defray co-pays, co-insurance and deductibles, but who may seek assistance from such foundations to help with these costs.

• Continue use of HHS’s Common PAP Application Form, requesting no additional information from applicants than is already requested on the current form, and participate in HarborPath to foster ease of access to medications through your PAPs. Both help to streamline the multiple forms and programs that provide HIV and Viral Hepatitiis medications to low-income individuals without health insurance.

• Disclose to the FPC the number of patients on your HIV and HCV access programs (i.e., co-pay assistance and PAPs), and your eligibility formulas for underinsured patients in your PAPs. Provide transparency on your PAP website(s) about the eligibility criteria for underinsured individuals.

ADAPs

• Continue providing significant, additional discounts/rebates to ADAPs beyond those required by the 340B program for all existing and new ARVs and DAAs.

• Provide full rebates on partial payments made by ADAPs, as is the current industry standard and guidance from HRSA, pending any changes in HRSA’s final rule on the topic.

The Fair Pricing Coalition (FPC) again censures Gilead Sciences for its drug pricing practices, this time for 7 percent price increases for Complera and Stribild—just six months after taking 7 percent and 5 percent price increases on the same antiretroviral (ARV) products in January.

“Gilead’s relentless pursuit of ARV market dominance, at the expense of public and private insurers and the American public, knows no bounds,” said FPC co-chair Lynda Dee. “This isn’t simply a cunning effort to squeeze profits out of both Complera and Stribild before one of their main components, tenofovir disoproxil (TDF), goes off patent; it’s also a scheme to maximize the number of people living with HIV using Gilead’s newer tenofovir alafenamide (TAF)-inclusive coformulations in advance of generic TDF-based regimens becoming available.”

Odefsey and Genvoya, newer versions of Complera and Stribild that contain TAF instead of TDF, were launched in the U.S. in November 2015 and March 2016, respectively, at wholesale acquisition cost (WAC) prices of $28,150 and $30,930 per year—both in parity with Complera and Stribild. With the July price increases, the WACs for Complera and Stribild are now $30,092 and $34,686 respectively, whereas the WAC prices for Odefsey and Genvoya remain the same.

TDF, Gilead’s 2001 breakthrough ARV for HIV and a component of Complera and Stribild (as well as Atripla and Truvada), is expected to come off patent in December 2017, with generic TDF-inclusive combination tablets becoming available in early 2018. Though TAF is equally efficacious and less likely to negatively affect markers of kidney and bone health compared with TDF, TDF remains a safe and effective component of ARV therapy for many people living with HIV. Coformulated with other generic medications, such as lamivudine, generic TDF may be a durable HIV treatment option associated with lower costs.

According to FPC member Tim Horn: “The July price increases are primarily indicative of an abhorrent tactic in an economic climate demanding a break from crushing healthcare costs: inflating the prices of older drugs to cast newer expensive drugs in an artificial light of being cheaper options. In turn, private insurers will either drop Complera or Stribild entirely or place even greater restrictions on their use, thereby hastening the uptake of Odefsey and Genvoya among people living with HIV. Once patients are started on or switched to TAF-inclusive regimens, it will be that much harder for patients and providers to seriously consider the merits of products containing generic TDF when they become available—and Gilead is banking on this.”

“FPC applauded Gilead for pricing its new TAF products, Odefsey and Genvoya, in parity with its older TDF products,” said Dee. “It suggested to us that Gilead was becoming cognizant of the systemic pitfalls of pricing medications beyond what the market can reasonably bear. Unfortunately, it didn’t take long for the company to manipulate HIV drug prices to fend off the threat of safe, effective, and potentially cheaper generic alternatives. It’s shameless.”
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The Fair Pricing Coalition, founded by the late Martin Delaney of Project Inform, is a national coalition of activists who work on HIV and viral hepatitis drug pricing issues, and to help control drug costs for patients who are privately insured, underinsured and uninsured. The FPC also works to ensure access for individuals covered by state AIDS Drug Assistance Programs (ADAPs), Medicare, and Medicaid. For more information about the Fair Pricing Coalition and its history, visit: fairpricingcoalititon.org.